EASY: Extended Access to Sollpura Over Years

Completed · Phase 4

Conditions studied: Exocrine Pancreatic Insufficiency, Cystic Fibrosis

In brief

Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be formulated without enteric coating for administration either as a capsule or as a dosing solution dissolved in water or juice.

Key facts

Study ID

NCT02823964

Run by

Anthera Pharmaceuticals

People needed

25

Starts

2016-09-01

Expected to finish

2018-03-01

Last updated by the study team

2018-05-17

Who can join

Age: 7 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects with cystic fibrosis-related exocrine pancreatic insufficiency who received liprotamase and completed Study AN-EPI3331 (SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis)

You may not qualify if…

• Any medical, psychological, or social condition that may put the subject at increased risk by participating in this study.
• Females who are nursing, pregnant, intending to become pregnant, or intending to nurse during the time of the study.

Where it is running

• Investigator Site 114 — Aurora, Colorado, United States
• Investigator Site 134 — Jackson, Mississippi, United States
• Investigator Site 121 — Burlington, Vermont, United States
• Investigator Site 501 — Brno, Czechia
• Investigator Site 303 — Debrecen, Hajdú-Bihar, Hungary
• Investigator Site 302 — Törökbálint, Pest County, Hungary
• Investigator Site 304 — Mosdós, Somogy County, Hungary
• Investigator Site 301 — Ajka, Veszprém megye, Hungary
• Investigator Site 601 — Jerusalem, Israel
• Investigator Site 203 — Karpacz, Poland
• Investigator Site 206 — Lodz, Poland
• Investigator Site 205 — Lublin, Poland
• Investigator Site 202 — Rabka-Zdrój, Poland
• Investigator Site 209 — Rzeszów, Poland
• Investigator Site 401 — Madrid, Spain

Full record on ClinicalTrials.gov

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